[Federal Register Volume 89, Number 76 (Thursday, April 18, 2024)]
[Notices]
[Pages 27767-27769]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-08293]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-4804]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Expedited Programs
for Serious Conditions--Drugs and Biologics
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by May 20, 2024.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0765. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Expedited Programs for Serious Conditions--Drugs and Biologics
OMB Control Number 0910-0765--Extension
This information collection supports regulations governing FDA
expedited programs for serious conditions. These provisions are set
forth in 21 CFR part 312, subpart E and are intended to speed the
availability of new therapies to patients with serious conditions,
especially when there are no satisfactory
[[Page 27768]]
alternative therapies, while preserving appropriate standards for
safety and effectiveness. The regulations call for earlier attention to
drugs that have promise in treating such conditions, including early
consultation with FDA for sponsors of such products. Respondents to the
information collection are sponsors of drug or biologic product
applications submitted to FDA.
To assist respondents with the information collection, we developed
Agency guidance entitled ``Guidance for Industry Expedited Programs for
Serious Conditions--Drugs and Biologics'' (May 2014). The guidance is a
resource for information on FDA's policies and procedures related to
the following expedited programs for serious conditions: (1) fast track
designation; (2) breakthrough therapy designation; (3) accelerated
approval; and (4) priority review designation, and describes threshold
criteria generally applicable to expedited programs, including what is
meant by serious condition, unmet medical need, and available therapy.
The guidance addresses the applicability of expedited programs to rare
diseases, clarification on available therapy, and additional detail on
possible flexibility in manufacturing and product quality. It also
clarifies the qualifying criteria for breakthrough therapy designation,
provides examples of surrogate endpoints and intermediate clinical
endpoints used to support accelerated approval, and priority review.
In addition, we developed Agency guidance entitled ``Expedited
Programs for Regenerative Medicine Therapies for Serious Conditions,''
(February 2019) describing the criteria for participation in the
Regenerative Medicine Advanced Therapy (RMAT) program. The RMAT
expedited program was approved as part of the 21st Century CURES Act,
signed December 13, 2016. An RMAT product is intended to treat, modify,
reverse, or cure serious or life-threatening diseases or conditions,
and preliminary clinical evidence indicate that the drug has the
potential to address unmet medical needs for such diseases or
conditions. This is a Center Biologics Evaluation and Research (CBER)
program and is included as an expedited program available for serious
conditions.
For a sponsor or applicant who seeks fast track, priority,
breakthrough, RMAT or accelerated approval designation review, approval
is required to submit a request showing that the drug product: (1) is
intended for a serious or life-threatening condition and (2) has the
potential to address an unmet medical need, demonstrate substantial
improvement over available therapy, or fill an unmet need to be
approved based on a surrogate endpoint. We expect that most information
to support a designation request will have been gathered under existing
requirements for preparing an investigational new drug (IND), new drug
application (NDA), or biologics license application (BLA). If such
information has already been submitted to us, the information may be
summarized in the designation request. A designation request should
include, where applicable, additional information not specified
elsewhere by statute or regulation. For example, additional information
may be needed to show that a product has the potential to address an
unmet medical need where an approved therapy exists for the serious or
life-threatening condition to be treated. Such information may include
clinical data, published reports, summaries of data and reports, and a
list of references. The amount of information and discussion in a
designation request should be sufficient to permit a reviewer to assess
whether the criteria for fast track, priority, breakthrough, RMAT or
accelerated approval designation have been met.
After we make an expedited programs designation, a sponsor or
applicant may submit a premeeting package that may include additional
information supporting a request to participate in certain expedited
programs. The premeeting package serves as background information for
the meeting and should support the intended objectives of the meeting.
As with the request for expedited programs designation, we expect that
most sponsors or applicants will have gathered such information to meet
existing requirements for preparing an IND, NDA, or BLA. These may
include descriptions of clinical safety and efficacy trials not
conducted under an IND (e.g., foreign studies) and information to
support a request for accelerated approval. If such information has
already been submitted to us, the information may be summarized in the
premeeting package.
The guidance documents are available on our website at www.fda.gov/regulatory-information/search-fda-guidance-documents and were issued
consistent with our good guidance practice regulations in 21 CFR
10.115, which provide for public comment at any time.
In the Federal Register of January 9, 2024 (89 FR 1101), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it was
not responsive to the four collection of information topics solicited.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden Total
respondents respondent responses per response hours
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CDER:
Priority Review Designation 81 1.53 124 30 3,720
Requests (Expedited Programs
for Serious Conditions Guidance
(EPSC) Section VIII)...........
Breakthrough Therapy Designation 71 1.08 77 70 5,390
Requests (EPSC Section VI).....
Fast Track Designation Requests 235 1.18 277 60 16,620
(EPSC Section V)...............
Accelerated Approval Designation 26 1.27 33 100 3,300
(EPSC Section VII).............
Premeeting Packages (21 CFR 163 1.01 165 100 16,500
312.82)........................
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CDER Subtotal............... .............. .............. 676 .............. 45,530
CBER:
Priority Review Designation 8 1 8 30 240
Request (EPSC Section VIII)....
Breakthrough Therapy Designation 15 1.1 17 70 1,190
Request (EPSC Section VI)......
Fast Track Designation Requests 64 1.2 77 60 4,620
(EPSC Section VII).............
RMAT Designation Requests 33 1.1 36 60 2,160
(Regenerative Medicine
Therapies for Serious
Conditions Guidance (RMAT)
Section III)...................
Premeeting Packages (RMAT 146 1.9 277 100 27,700
Section V).....................
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CBER Subtotal............... .............. .............. 415 .............. 35,910
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[[Page 27769]]
Total................... .............. .............. 1,091 .............. 81,440
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on FY 2022 receipts, we estimate that for Center for Drug
Evaluation and Research (CDER) products, 81 respondents will submit 124
requests for priority review designation annually, and we assume 30
hours are needed to prepare such a request. We estimate 71 respondents
will submit 77 requests for breakthrough designation annually, and we
assume 70 hours are needed to prepare such a request. We estimate that
235 respondents will submit 277 requests for fast-track designation
requests annually, and we assume 60 hours are required to prepare such
a request. We estimate 26 respondents will submit 33 accelerated
approval designation requests annually and we assume 100 hours are
required to prepare such a request. Finally, CDER received 165 pre-
meeting package submissions from 163 respondents. We assume 100 hours
are needed to prepare a pre-meeting package.
Similarly, also based on FY 2022 receipts, we estimate that for
CBER products, 8 applicants will submit 8 requests for priority review
designation annually, and we assume 30 hours are required to prepare
such a request. We estimate 15 respondents will submit 17 requests for
breakthrough designation annually, and we assume 70 hours are needed to
prepare such a request. We estimate that 64 respondents will submit 78
requests for fast-track designation annually, and we assume 60 hours is
required to prepare such a request. We also estimate 33 respondents
will submit 35 requests for RMAT designation annually and assume that
60 hours are needed to prepare each RMAT designation request. Finally,
CBER received 283 pre-meeting package submissions from 146 respondents.
We assume 100 hours are needed to prepare a pre-meeting package.
Based on a review of the information collection since our last
request for OMB approval, we have increased our burden estimate by 143
responses and 10,350 hours to reflect actual submissions we have
received. We attribute these changes to increased interest in the
expedited programs, new expedited programs, and an increase in the
number of submissions we received over the last few years.
Dated: April 15, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-08293 Filed 4-17-24; 8:45 am]
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